Computer System Validation Remote Jobs in Newtown, PA

Reports to: Senior Vice President, Technical Operations

Location: Remote or Plymouth Meeting, PA (Hybrid)

Company Overview:

Braeburn is dedicated to delivering solutions for people living with the serious consequences of opioid use disorder. At Braeburn, we challenge the status quo and champion transformation of the management of opioid use disorder (OUD) by partnering with the community to create a world where every person with OUD gets the best possible care and opportunity to reach their full potential. Our shared commitment to innovation on behalf of patients enables us to help people with OUD begin and sustain recovery.

At Braeburn, there are opportunities to contribute to our purpose every day. We value authenticity and strive to amplify all voices. Our culture empowers everyone to be successful and unleashes our full potential. 

Position Summary:

The Director of Clinical Quality Assurance (CQA) is responsible for developing, implementing, and maintaining the company's Clinical Quality Management System (QMS) to ensure compliance with Good Clinical Practices (GCP) regulatory requirements and industry standards. This role provides oversight of all third-party vendors involved in clinical development, including CROs, laboratories, and suppliers, ensuring adherence to Good Clinical Practice (GCP) and inspection readiness for regulatory agencies.

This role partners closely with Clinical Operations and Medical Affairs leadership to ensure clinical trial execution, oversight, and medical activities are conducted in compliance with GCP, regulatory expectations, and internal quality standards.

Specific Duties: 

Quality Management System

• Leads all Clinical Quality Assurance (QA) activities within the company
• Develops, implements, and maintains all clinical quality assurance systems, processes, and procedures
• Develops and tracks clinical quality metrics, approves all deviations, and develops Corrective and Preventative Actions (CAPAs)
• Lead management review meetings and ensure continuous improvement.
• Maintain inspection readiness for sponsor and regulatory inspections (FDA, EMA).

Quality Oversight of CROs and Vendors

• Qualifies and audit CROs and clinical suppliers per internal SOPs.
• Monitors CRO performance and ensures compliance with GCP and company standards.
• Reviews CRO documentation (e.g., SOPs, TMF, risk management plans) for adequacy.

Risk and Compliance

• Implements proactive risk identification and mitigation processes.
• Coordinates clinical site audits and ensure timely resolution of findings.
• Ensures compliance with ICH guidelines, FDA regulations, and Part 11 requirements.

Training and Communication

• Build and roll out QA training programs for internal staff and CRO partners.
• Serve as the primary QA contact for clinical teams and external partners.

Skills:

• Established GCP QA professional
• Robust understanding of quality management systems and GxP to ensure compliance with regulatory requirements
• Excellent critical data analysis, written, and oral communication skills
• Strong experience in QA Audits of Clinical sites and Third-party organizations
• Demonstrated ability to successfully interact with regulatory health authorities at inspections as well as lead all preparation, hosting, and follow-up activities
• Ability to lead and influence cross functional employees to ensure compliance, and able to enhance team performance through strong collaboration skills
• Robust knowledge of successful delivery of a clinical study, e.g., ICH-GCP, study management, site management, monitoring, SOPs, training, etc.

Education/Experience:

• BA/BS in related field with at least 10 years of Quality Assurance experience in pharmaceutical GCP operations or related quality technical role in the medical space
• Deep knowledge of international guidelines ICH-GCP as well as relevant local regulations
• Significant experience with QA review of Clinical Protocols, CAPA reports, SOPs, change control processes, deviation/investigation reports, computer systems validation, QA agreements, audit reports
• Experience utilizing QMS metrics, KPIs, and QTLs to assess risks to clinical research and drug development processes
• Demonstrated expertise in leading organizational and planning activities

Braeburn is committed to ensuring equal employment opportunity for all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, military/veteran status, age, disability, or any other category/characteristic protected by law (collectively, "Protected Categories"). In fact, we encourage all underrepresented backgrounds to apply for any open job positions with the company.

Braeburn Job Scam Warning
At Braeburn, we prioritize the security of your personal information. Be aware of individuals falsely presenting themselves as Braeburn employees or representatives to gain access to your personal information or money through fictitious job offers.
Braeburn will never ask for financial information or payment during the job application process. This includes but it is not limited to requests for bank account details, social security numbers, credit card numbers, or any form of payment for application fees, equipment, or software. Any claims that you will be reimbursed for such expenses are fraudulent.
We also will not ask you to download third-party applications for communication regarding job opportunities. Be cautious of offers from unofficial email addresses (e.g., Yahoo, Gmail, Hotmail) or those with misspelled variations of official Braeburn email addresses.
To ensure you are communicating about a legitimate job opportunity, check that the job is posted on Braeburn's official career website. If you suspect you have been contacted about a fraudulent position, please contact Braeburn directly through our official channels at info@braeburnrx.com. 
Braeburn is not liable for losses resulting from job recruiting scams. If you believe you are a victim of fraud, contact the FBI through the Internet Crime Complaint Center at https://www.ic3.gov or your local authorities.
Braeburn does not accept unsolicited assistance from search firms for employment opportunities. Resumes submitted without a valid written search agreement will be considered Braeburn's sole property, and no fee will be paid.